ID

21861

Beschreibung

Study of Cipterbin®, Used Alone or With Vinorelbine in Patients With HER2/Neu-overexpressed Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01439191

Link

https://clinicaltrials.gov/show/NCT01439191

Stichworte

Versionen (1)
  1. 04.05.17 04.05.17 -
Hochgeladen am

4. Mai 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Metastatic Breast Cancer NCT01439191

Englisch

Eligibility Metastatic Breast Cancer NCT01439191

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologic diagnosis breast cancer
Beschreibung

Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0678222
her2+ status defined as ihc3+ staining or in situ hybridization positive at least 1 measurable lesion as per recist criteria
Beschreibung

HER2/Neu Positive | Immunohistochemistry Score | In Situ Hybridization Positive | Measurable Disease Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C2348909
UMLS CUI [2,1]
C0021044
UMLS CUI [2,2]
C0449820
UMLS CUI [3,1]
C0162788
UMLS CUI [3,2]
C1514241
UMLS CUI [4,1]
C1513041
UMLS CUI [4,2]
C1265611
adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)
Beschreibung

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
adequate liver (bilirubin <1.0 times upper limit of normal and sgot/sgpt <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)
Beschreibung

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0232804
UMLS CUI [6]
C0201976
adequate cardiac function (lvef>50%). normal electrocardiogram and absence of significant heart disease
Beschreibung

Cardiac function | Left ventricular ejection fraction | ECG normal | Heart Disease Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0428772
UMLS CUI [3]
C0522054
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0332197
age from 18 to 70y
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
karnofsky performance score ≥ 60
Beschreibung

Karnofsky Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
life expectancy of greater than 3 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
negative hcg pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause.
Beschreibung

Childbearing Potential Hcg pregnancy test Negative | Premenopausal state | Postmenopausal state Duration Hcg pregnancy test Negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0546577
UMLS CUI [1,3]
C1513916
UMLS CUI [2]
C0232969
UMLS CUI [3,1]
C0232970
UMLS CUI [3,2]
C0449238
UMLS CUI [3,3]
C0546577
UMLS CUI [3,4]
C1513916
signed icf
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior exposure vinorelbine for breast cancer
Beschreibung

Vinorelbine Exposure | Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0078257
UMLS CUI [1,2]
C0332157
UMLS CUI [2]
C0678222
prior exposure trastuzumab for breast cancer
Beschreibung

Trastuzumab Exposure | Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0728747
UMLS CUI [1,2]
C0332157
UMLS CUI [2]
C0678222
prior chemotherapy and radiation therapy within the last 4 weeks before enrollment
Beschreibung

Chemotherapy | Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
use of any other investigational agents within the last 4 weeks before enrollment
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
symptomatic, central nervous system metastases
Beschreibung

CNS metastases Symptomatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
hypersensitivity to trial medications
Beschreibung

Hypersensitivity Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
breastfeeding or pregnant
Beschreibung

Breast Feeding | Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Metastatic Breast Cancer NCT01439191

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma
Item
pathologic diagnosis breast cancer
boolean
C0678222 (UMLS CUI [1])
HER2/Neu Positive | Immunohistochemistry Score | In Situ Hybridization Positive | Measurable Disease Quantity
Item
her2+ status defined as ihc3+ staining or in situ hybridization positive at least 1 measurable lesion as per recist criteria
boolean
C2348909 (UMLS CUI [1])
C0021044 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
C0162788 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C1513041 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
adequate liver (bilirubin <1.0 times upper limit of normal and sgot/sgpt <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Cardiac function | Left ventricular ejection fraction | ECG normal | Heart Disease Absent
Item
adequate cardiac function (lvef>50%). normal electrocardiogram and absence of significant heart disease
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
C0522054 (UMLS CUI [3])
C0018799 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Age
Item
age from 18 to 70y
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky performance score ≥ 60
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of greater than 3 months
boolean
C0023671 (UMLS CUI [1])
Childbearing Potential Hcg pregnancy test Negative | Premenopausal state | Postmenopausal state Duration Hcg pregnancy test Negative
Item
negative hcg pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause.
boolean
C3831118 (UMLS CUI [1,1])
C0546577 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C0232969 (UMLS CUI [2])
C0232970 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C0546577 (UMLS CUI [3,3])
C1513916 (UMLS CUI [3,4])
Informed Consent
Item
signed icf
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Vinorelbine Exposure | Breast Carcinoma
Item
prior exposure vinorelbine for breast cancer
boolean
C0078257 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
Trastuzumab Exposure | Breast Carcinoma
Item
prior exposure trastuzumab for breast cancer
boolean
C0728747 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
Chemotherapy | Therapeutic radiology procedure
Item
prior chemotherapy and radiation therapy within the last 4 weeks before enrollment
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Investigational New Drugs
Item
use of any other investigational agents within the last 4 weeks before enrollment
boolean
C0013230 (UMLS CUI [1])
CNS metastases Symptomatic
Item
symptomatic, central nervous system metastases
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Hypersensitivity Investigational New Drugs
Item
hypersensitivity to trial medications
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Breast Feeding | Pregnancy
Item
breastfeeding or pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video